Agenda:

Day One


Lecture 1:

Introduction to the FDA

  • How the regulations help your company to be successful
  • Which data and systems are subject to Part 11

Lecture 2:

21 CFR Part 11/Annex 11 - Compliance for Electronic Records and Signatures

  • What Part 11 means to you, not just what it says in the regulations
  • Avoid 483 and Warning Letters
  • Explore the three primary areas of Part 11 compliance: SOPs, software product features, and validation documentation
  • How SaaS/cloud computing changes qualification and validation
  • Ensure data integrity, security, and protect intellectual property
  • Understand the current computer system industry standards for security, data transfer, and audit trails
  • Electronic signatures, digital pens, and biometric signatures
  • SOPs required for the IT infrastructure
  • Product features to look for when purchasing COTS software
  • Reduce validation resources by using easy to understand fill-in-the-blank validation documents

Lecture 3:

The Five Keys to COTS Computer System Validation

  • The Who, What, Where, When, and Why of CSV

Day Two

Lecture 1:

Ten-Step Process for COTS Risk-Based Computer System Validation

  • Learn which documents the FDA expects to audit.
  • How to use the risk-based validation approach to lower costs.
  • How to link requirements, specifications, risk management, and testing.
  • Document a computer system validation project using easy to understand fill-in-the-blank templates.
  • Based on: "Risk-Based Software Validation - Ten Easy Steps" (Davis Horwood International and PDA - www.pda.org, 2006).

Lecture 2:

How to Write Requirements and Specifications

  • Workshop for writing requirements and then expanding them for specifications

Lecture 3:

How to Conduct a Hazard Analysis/Risk Assessment-Exercise

  • Step-by-step instructions for performing and documenting a risk assessment, and how to use the results to reduce validation documentation.

Lecture 4:

Software Testing

  • Reduce testing by writing test cases that trace to elements of risk management.
  • How to write efficient test cases

Lecture 5:

System Change Control

  • How to manage a validated system with minimal documentation

Lecture 6:

Purchasing COTS Software

  • How to purchase COTS software and evaluate software vendors.

Lecture 7:

Cost Reduction Without Increasing Regulatory or Business Risk

  • How to save money
  • How to increase quality
  • How to increase compliance with less documentation

You can register for this seminar paying either by cheque or Demand Draft. To register, please make out your cheque or Demand Draft for the prescribed amount and send it to the address given below:
NetZealous Services India Pvt. Ltd.
Gururaya Mansion, 759 to 764, 8th Main road, J.P.Nagar,
Bangalore - 560078 Karnataka, INDIA

  • Group participations
  • Discount Slab: 5 or more participants 10% discount
    To avail the above group discounts, all the participants should register by making a single payment.
  • Call our representative TODAY on 7676504662 to have your seats confirmed!
  • Quick Contact
    Toll free: 1800 425 9409
    Email: Customer Support
  • Want to register by Wire Transfer?
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    Bank Name: ICICI Bank
    Account Name: NetZealous Services India Private Limited
    Account Type: Current Account
    Account Number: 100705001045
    IFSC Code: ICIC0001007
    MICR Code: 560229039
    Branch Address: ICICI Bank, Bannerghatta Road, Bangalore - 560076

Venue:

The Leela Mumbai Andheri Kurla Road, Sahar Village, Andheri-Kurla Road, Mumbai, Maharashtra 400059

Speaker:

David Nettleton

Director & FDA Compliance Specialist,
Computer System Validation and FDA Compliance consultant

Computer System Validation's principal, David Nettleton is an industry leader, author, and teacher for 21 CFR Part 11, Annex 11, HIPAA, software validation, and computer system validation. He is involved with the development, purchase, installation, operation and maintenance of computerized systems used in FDA compliant applications. He has completed more than 260 mission critical laboratory, clinical, and manufacturing software implementation projects. His most popular book is Risk Based Software Validation - Ten easy Steps, which provides fill-in-the-blank templates for completing a COTS software validation project.

Services are available to guide companies to create and maintain the systems and procedures required to pass regulatory inspections: product features, vendor audits, software validation, SOPs, training, gap analysis, remediation plans, and project management.

Projects involve: medical devices, blood bank, clinical trial, corrective action, document control, electronic data capture, Excel spreadsheets, laboratory instruments, laboratory information management (LIMS), manufacturing, enterprise resource planning, toxicology systems, and VMWare.

David Nettleton is also the co-author of:

  • Managing the Documentation Maze - Answers to Questions You Didn't Even Know to Ask (Wiley - www.wiley.com) 2010
  • Electronic Record Keeping; Achieving and Maintaining Compliance with 21 CFR Part 11 and 45 CFR Parts 160, 162, and 164 (Interpharm/CRC - www.crcpress.com, 2004)
  • Commercial Off-the-Shelf (COTS) Software Validation for 21 CFR Part 11 Compliance (Davis Horwood International and PDA - www.pda.org, 2003).

Mumbai Local Attractions

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Mani Bhavan Gandhi Museum

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Bandra-Worli Sea Link

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Marine Drive

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Gateway of India

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Chowpatty Beach

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Chhatrapati Shivaji Terminus

Our Address

NetZealous Services India Pvt. Ltd.

Gururaya Mansion, 759 to 764, 8th Main road, J.P.Nagar,

Bangalore - 560078 Karnataka,INDIA.

Toll free: 1800 425 9409

Call: 7676504662